MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY

Catalog Number 295400-001

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue did not prevent the freedom driver from performing its life sustaining functions.In addition, the freedom driver has a redundant power source of multiple onboard batteries.The freedom hospital ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that a piece of the freedom hospital ac power supply was broken.

Manufacturer Narrative

Visual inspection of the power supply revealed multiple chips, cracks and seam separation to the body of the power supply brick.The hypertronics connector was found to have internal and external damage resulting in the inability to keep the outer housing of the connector on the device.The root cause of this damage could not be conclusively determined, but given the observations made during the visual inspection, it is likely the result of a drop or other rough handling.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8033902
• MDR Text Key: 127886893
• Report Number: 3003761017-2018-00523
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295400-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR